Cleared Special

K221487 - NEOVEIL Staple Line Reinforcement (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K221487 · Gunze Limited · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Aug 2022
Decision
95d
Days
Class 2
Risk

K221487 is an FDA 510(k) clearance for the NEOVEIL Staple Line Reinforcement. Classified as Mesh, Surgical, Absorbable, Staple Line Reinforcement (product code OXC), Class II - Special Controls.

Submitted by Gunze Limited (Ayabe, Kyoto, JP). The FDA issued a Cleared decision on August 26, 2022 after a review of 95 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Gunze Limited devices

Submission Details

510(k) Number K221487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2022
Decision Date August 26, 2022
Days to Decision 95 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 114d · This submission: 95d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OXC Mesh, Surgical, Absorbable, Staple Line Reinforcement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists During Staple Line Reinforcement Procedures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Emergo Global Consulting, LLC
Stuart R. Goldman

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.